Jaques Kilian

Clinical Data Team Lead with 5+ years of progressive CRO Clinical Data Management experience and 4+ years leading global data management projects across Phase I-IV studies. Primary sponsor-facing Data Management lead with end-to-end responsibility from study set-up through database lock and close-out. Experienced in protocol review, Data Management Plan development and maintenance, CRF/eCRF and database design activities, validation requirements, UAT, data review and query resolution, MedDRA/WHO Drug coding oversight, external data integration, eCOA/IRT data, SAE reconciliation, metrics, risk management and audit readiness.

Strong working knowledge of ICH-GCP, 21 CFR Part 11, sponsor and CRO SOPs, clinical data systems, and complex multinational trials.

Clinical Data Team Lead - PPD (Pharmaceutical Products Development), part of Thermo Fisher Scientific - South Africa

(2022-02)

• Lead the entire Clinical Data Management lifecycle across global, multi-center Phase I-IV studies from study set-up and maintenance through database lock and close-out, with accountability for data quality, timelines, milestones and deliverables.
• Serve as primary Data Management contact for sponsors, project leads and cross-functional teams; lead sponsor, internal and kick-off meetings and resolve study-level Data Management issues.
• Lead study set-up activities including requirements gathering, CRF/eCRF design, data-flow definition, validation requirements and database set-up; oversee database modifications and lead or perform UAT of study-specific systems and applications.
• Review study protocols from a Data Management perspective and develop, review and maintain Data Management Plans and related study documentation to define data handling, review, reconciliation, quality and close-out activities.
• Provide coding oversight for clinical data using MedDRA and WHO Drug dictionaries, supporting consistent coding review and resolution in accordance with study and sponsor requirements.
• Oversee data review, cleaning, discrepancy and query processing/resolution to support accurate, consistent and inspection-ready clinical data.
• Coordinate integration and reconciliation of external data with programming, biostatistics, clinical operations, laboratories and vendors, including laboratory, device, eCOA and IRT data; support cross-system and SAE reconciliation.
• Develop and review project documentation, study tracking information, metrics reports and timelines; identify delivery risks and implement corrective actions when projects are off track.
• Manage scopes of work against contractual obligations and negotiate Data Management timelines and resource needs with relevant stakeholders.
• Ensure compliance with ICH-GCP, 21 CFR Part 11 principles, regulatory requirements, internal and sponsor SOPs, quality-control expectations and audit-readiness requirements.
• Mentor and train junior Data Management staff, lead study-specific training, share best practices and coordinate work across functional teams.

Associate Clinical Data Manager - IQVIA - South Africa

(2021-03 - 2022-01)

• Performed clinical data review and cleaning, identified and resolved discrepancies and queries, and supported consistent data quality.
• Supported Data Team Leads across the full Data Management lifecycle from study start-up through database lock and close-out.
• Participated in sponsor and internal meetings, including kick-offs and audits; tracked timelines, risks, KPIs and quality deliverables.
• Worked in accordance with IQVIA and sponsor SOPs and supported project delivery against defined quality and timeline expectations.

Associate Pastor - Associate Pastor, Bloemfontein Baptist Church

(2007 - 2021)

Earlier career developed extensive people leadership, training, counselling, stakeholder communication, healthcare collaboration and information-quality disciplines.

Zone Pastor - Christian Revival Church

(2000 - 2007)

Vocational Counselor - Department of Labour

(1997 - 2000)

Theatre Medical Ordnance - South African Medical Services

(1991)

Honours Degree - Psychology - University of the Free State (1996)

Bachelor of Social Science - Social Science - University of the Free State (1994)

Bachelor of Theology - Theology - Baptist Theological College of Southern Africa (2017)

Bachelor of Theology - Theology - South African Theological Seminary (2014)